NCT04635904

Brief Summary

This study will recruit 100 participants who self-report high symptoms of social anxiety (Social phobia inventory \>30). Participants will be randomly assigned to receive either one analog intervention of Imagery Rescripting (IR) or Imaginal Exposure. We will test the efficacy and mechanisms behind each interventions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 26, 2022

Status Verified

October 1, 2022

Enrollment Period

2.3 years

First QC Date

November 8, 2020

Last Update Submit

October 25, 2022

Conditions

Keywords

Social anxiety symptoms

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the Social phobia inventory (SPIN) at the follow-up session

    The SPIN is a validated self-report instrument assessing average social phobia symptom intensity over the past week. possible scores range from 0 (not at all) to 4 (Extremly). change = (follow-up score - Baseline Score)

    Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

Secondary Outcomes (11)

  • Change from Baseline in the Thought fusion inventory (TFI) at the follow-up session

    Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

  • Change from Baseline in the White Bear Suppresion inventory (WBSI) at the follow-up session

    Will be measured at Baseline (6,9, or 12 days before intervention), Post-intervention (immediately after the intervention) and Follow-up ( 7 days after the intervention)

  • Change from Baseline in the Positive and Negative Affect Scale (PANAS) international version short form (10 items from the negative subscale only) at the follow-up session

    Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

  • Change from Baseline to follow-up in the amount of negative and positive/neutral content details the participant provides while describing the negative imagery. The imagery will be probed using the Waterloo Image and Memories Interview (WIMI).

    Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

  • Change from Baseline to follow-up in negativity of the core-beliefs that the participant link to the negative imagery provided in the WIMI.

    Will be measured at Baseline (6,9, or 12 days before intervention) and Follow-up ( 7 days after the intervention)

  • +6 more secondary outcomes

Other Outcomes (1)

  • Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

    Baseline only

Study Arms (2)

Imaginal exposure

EXPERIMENTAL

A behavioral intervention in imagery

Behavioral: Imaginal exposure one-session

Imagery rescripting

EXPERIMENTAL

A different behavioral intervention in imagery

Behavioral: Imagery rescriptinf one-session

Interventions

Participants in this arm will be asked to decide alongside with the intervention provider (a clinical PhD student or M.A student under the supervision of the principal investigator) to imagine a script based on a future distressing anxiety provoking scenarios multiple times while honing in on the most negative aspects.

Imaginal exposure

Participants in this arm will be asked to decide alongside with the intervention provider (a clinical PhD student or M.A student under the supervision of the principal investigator) o imagine a script based on a future distressing anxiety provoking scenarios one time while honing in on the most negative aspects. Afterwards they will insert changes into the script that try to help them cope in the imagery.

Imagery rescripting

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • can't report a negative imagery related to a future social scenario. Attending active psychotherapy sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebrew University of Jerusalem

Jerusalem, 9190501, Israel

RECRUITING

Related Publications (6)

  • Aderka IM, Pollack MH, Simon NM, Smits JA, Van Ameringen M, Stein MB, Hofmann SG. Development of a brief version of the Social Phobia Inventory using item response theory: the Mini-SPIN-R. Behav Ther. 2013 Dec;44(4):651-61. doi: 10.1016/j.beth.2013.04.011. Epub 2013 May 3.

    PMID: 24094790BACKGROUND
  • Connor KM, Davidson JR, Churchill LE, Sherwood A, Foa E, Weisler RH. Psychometric properties of the Social Phobia Inventory (SPIN). New self-rating scale. Br J Psychiatry. 2000 Apr;176:379-86. doi: 10.1192/bjp.176.4.379.

    PMID: 10827888BACKGROUND
  • Muris P, Merckelbach H, Horselenberg R. Individual differences in thought suppression. The White Bear Suppression Inventory: factor structure, reliability, validity and correlates. Behav Res Ther. 1996 May-Jun;34(5-6):501-13. doi: 10.1016/0005-7967(96)00005-8.

    PMID: 8687372BACKGROUND
  • Romano M, Moscovitch DA, Saini P, Huppert JD. The effects of positive interpretation bias on cognitive reappraisal and social performance: Implications for social anxiety disorder. Behav Res Ther. 2020 Aug;131:103651. doi: 10.1016/j.brat.2020.103651. Epub 2020 May 22.

    PMID: 32504886BACKGROUND
  • Moscovitch DA, Vidovic V, Lenton-Brym AP, Dupasquier JR, Barber KC, Hudd T, Zabara N, Romano M. Autobiographical memory retrieval and appraisal in social anxiety disorder. Behav Res Ther. 2018 Aug;107:106-116. doi: 10.1016/j.brat.2018.06.008. Epub 2018 Jun 22.

    PMID: 29960125BACKGROUND
  • Tolin DF, Gilliam C, Wootton BM, Bowe W, Bragdon LB, Davis E, Hannan SE, Steinman SA, Worden B, Hallion LS. Psychometric Properties of a Structured Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders. Assessment. 2018 Jan;25(1):3-13. doi: 10.1177/1073191116638410. Epub 2016 Mar 17.

    PMID: 26988404BACKGROUND

Study Officials

  • Jonathan D Huppert, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Snir Barzilay, Grad student

CONTACT

Jonathan D Huppert, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor that assess mental imagery content (see secondary outcomes) are blind to the condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD, Certified Clinical Psychologist

Study Record Dates

First Submitted

November 8, 2020

First Posted

November 19, 2020

Study Start

April 19, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

October 26, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations